Manager - Regulatory Affairs | Leading Pharma MNC

Hindco Recruitment Consultants; Faridabad District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Hindco Recruitment Consultants seeks a regulatory affairs professional with 5+ years in pharma/regulatory roles to ensure MDR2017 compliance for SaMD and medical devices in India, EU, and US. You will manage CDSCO submissions, liaise with authorities, and maintain core technical documentation.

Knowledge of SaMD regulations is a plus, with collaboration across QA/R&D to enable safe market access and ongoing regulatory updates.

Qualifications

• B.Pharm/M.Pharm with 5+ years of pharma/regulatory experience.
• Strong understanding of medical device regulations (India, EU, US).
• Knowledge of SaMD regulations is a plus.

Responsibilities

• Ensures compliance with MDR 2017 and global regulations.
• Manages CDSCO submissions, authority liaison, and core technical docs.
• Tracks regulatory updates; works with QA/R&D to enable safe market access for SaMD & implants.

Skills

Regulatory affairs

MDR 2017 compliance

Education

B.Pharm/M.Pharm

Job description

• Ensures compliance with MDR 2017 and global regulations.
• Manages CDSCO submissions, authority liaison, and core technical docs.
• Tracks regulatory updates; works with QA/R&D to enable safe market access for SaMD & implants.

Required Candidate profile

• B.Pharm/M.Pharm with 5+ years of experience in Pharma.
• Strong understanding of medical device regulations (India, EU, US).
• Knowledge of Medical Device Software (SaMD) regulations is a plus.